Assistant professor, School of Bacteriology and Clinical Laboratory, Universidad del Valle, Cali, Colombia.
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Abstract 1
Analytical performance specifications
The information provided by the laboratory is fundamental for clinical decision-making; therefore, it is essential that the laboratory guarantees that the determinations it performs meet the quality standards necessary for their clinical utility. Analytical quality can be estimated using various indicators, such as random error, systematic error, total error, among others. It is advisable to define analytical performance specifications (APS) for these components of analytical error or variation in order to ensure the reliability of information regarding patients' health status. Although different terms are used to refer to APS, the truth is that regardless of the expression used, analytical quality requirements are fundamental to ensuring quality in the clinical laboratory, and defining them involves understanding the analytical objective, observing that the assay meets the objectives, establishing performance with the test, determining alarms and limits, and applying quality control tools for each step. The aim of this talk is to present the different quality specifications and their practical use.
Abstract 2
Sigma Metric in clinical laboratory
Six Sigma is a process improvement tool implemented to reduce process variability. One approach involves quantifying the percentage of defects, converting them to a defects per million (DPM) rate, and then using a table to find the appropriate sigma metric. A second approach involves measuring process variation to estimate the sigma metric. In the clinical laboratory, both concepts can be applied depending on the laboratory phase in which the metric is used. A process is considered efficient and of high quality when it achieves 6 sigma. This presentation aims to demonstrate the usefulness of the metric in the clinical laboratory process phases and different strategies that link sigma-based performance of the analytical process with the validation rules for analytical runs.
Abstract 3
Pre-analytical phase: compliance with ISO 20658:2023
A critical aspect of clinical laboratory services is the collection and transport of samples to the clinical laboratory for analysis. These activities, which also include sample reception and handling, constitute the pre-analytical phase.
This standard provides the requirements for all activities related to sample collection and transport to ensure the quality and reliability of results for patient healthcare. Clinical laboratory sample collection and transport can be carried out in various settings: hospitalized patients, outpatients; at home or wherever the patient is located; among others.
Whatever the setting, it is necessary to identify the requirements to be met to minimize incorrect patient results. Therefore, this presentation aims to provide tools for quality and competence for those who collect and transport samples to clinical laboratories.